Mary Rose Magie Yap
Daly City,CA
Summary
Detail-oriented team player with 10 years of experience in pharmacovigilance. Expertly collects, organizes, analyzes and disseminates significant amounts of information with attention to detail, accuracy and efficiency.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Ability to handle multiple projects simultaneously with a high degree of accuracy and excellent investigative and problem solving skills.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Global Safety Reporting Specialist (I&EC)
Janssen, A Johnson & Johnson Company
11.2021 - Current
- Acted as delegate to more senior staffs and mentored, supervised and peer reviewed more junior staff.
- Led and supported various activities such as quality monitoring, process/system improvements and troubleshooting, compliance related queries, quality investigations, CAPA activities, identifying/resolving general issues, and global safety reporting initiatives. (ex. SafetyPortal 3.0, DSUR CAPA, Medical device implementation, etc.)
- Managed process training/presentation. Prepared training materials and delivered training and presentations within safety reporting and cross functional groups.
- Managed customer and stakeholder relationships, coordinating requests and ensuring effective communication and collaboration. (ex. Quality, Compliance, CROs, Regulatory, Clinical teams, Other safety groups, System groups and Vendors)
- Oversaw Clinical Trial Safety Reporting Systems/process as business and/or system owner/delegate/SME. Planned, prepared, coordinated, tested, documented, and implemented all system/process related updates and changes.
- Collaborated with vendors, conducted system validations, investigations, improvements and provided support during audits/inspections. (ex. BRQC audits, DSUR CAPA, CAR investigation, SP 3.0, etc.)
- Managed and led System and Application Management system (SAM) query resolutions.
- Managed SafetyPortal implementation/maintenance of new/existing compounds, studies, users, and communicated/collaborated with service users and all involved partners. (ex. SAM queries, Annual User review, monthly compound review, etc.)
- Managed SUSAR/SUSAR LL/DSUR related activities, including safety report search, distribution, troubleshooting, investigations, documentation/process maintenance, improvements, and communication/collaboration with stakeholders.
- Reviewed and updated service agreements/contracting activities with existing and future contract partners and service users. (ex. POM, TOM, ASMPs)
- Managed SafetyPortal and ensured quality control by reviewing and updating/creation of SOPs, Job aids, guidance documents, forms, functional Homepages, and training materials. Performing system and process annual reviews.
- Made significant contributions to the team. Led investigations, documentation, queries, troubleshooting, process improvements, and compliance tracking.
- Maintained compliance with training requirements and stayed updated on worldwide regulations and guidance.
Senior Intake Specialist
Janssen, A Johnson & Johnson Company
04.2020 - 10.2021
- Conducted initial review and seriousness assessment of cases within Global Inbound Receipt System.
- Supported case intake activities, including database entries, translation requests, and liaising with stakeholders.
- Managed AE/Product Quality Complaints referral process, reconciliation, quality and compliance related tasks and case un-blinding.
- Monitored global inbound mailboxes, addressed technical issues, and implemented emergency procedures.
- Supported due diligence activities by generating letters and following up on contact information.
- Assisted with archival and retrieval of adverse event-related information.
- Participated in User Acceptance Testing for system upgrades/enhancements.
- Interacted with other Drug Safety units and contributed to maintaining global procedures and guidelines.
- Managed, performed oversight, and collaborated with key pharmaceutical partners to ensure timely receipt of safety reports. (i.e. Express scripts)
- Performed key regulatory tasks to ensure compliance. (i.e. Philips ineb exchange)
- - Participated and a key contributor on department projects, initiatives, investigations, troubleshooting, process improvement and implementation. (i.e. E2E project)
Drug Safety Coordinator/Intake Specialist
Janssen, A Johnson & Johnson Company
09.2014 - 03.2020
- Entered and validated adverse event information in drug safety database for investigational and post-marketing products.
- -Reviewed, evaluated, and tracked adverse event information from initiation to submission.
- Prepared and submitted adverse event information to regulatory authorities.
- Followed up on cases, prepared queries, and assisted in summary report preparation.
- Interacted with other Drug Safety units and contributed to maintaining global procedures and guidelines.
- Provided support for various reports and participated in department projects.
Education
Bachelor of Science - Cell And Molecular Biology
San Francisco State University
San Francisco, CA05.2000
Skills
- Operational Efficiency and attention to detail
- Administration and Management
- Work Organizing and Prioritizing
- Progress Monitoring
- Reporting and Analysis
- Reporting Efficiency and Accuracy
- Easily adapt to any work environment
- Safety reporting data Systems: SafetyPortal, OST, IRT, ArisG, SAM, Hubstor, vTMF, Viper, etc
- Microsoft office: PowerPoint Presentations, Word, Excel, etc
- Microsoft office: PowerPoint Presentations, Word, Excel, etc
Certification
Certificate in Clinical Trial Management
Timeline
Senior Global Safety Reporting Specialist (I&EC)
Janssen, A Johnson & Johnson Company
11.2021 - Current
Senior Intake Specialist
Janssen, A Johnson & Johnson Company
04.2020 - 10.2021
Drug Safety Coordinator/Intake Specialist
Janssen, A Johnson & Johnson Company
09.2014 - 03.2020
Bachelor of Science - Cell And Molecular Biology
San Francisco State University
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